None listed
Conditions
Interventions
GROUP 1 Type of group
It will start with 2 weeks of L-000899055 PLACEBO once per day. Subsequent to randomization, this group will continue with L-000899055 PLACEBO once per day for 108 weeks.
Group name:GROUP 5 Type of group
It will sIt will start with 2 weeks of L-000899055 PLACEBO once per day. After randomization, this group will continue with L-000899055 2 mg once a day for 2 weeks, 4 mg of L-000899055 for the third and fourth week and finally 6 mg of L-000899055 from the fifth week until 108 weeks of treatment
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: a) The patient has a body mass index (BMI) between 30 kg / m2 and 43 kg / m2. b) The patient meets at least 1 of the following 4 criteria in Visit 1: 1) Triglyceride levels> 150 mg / dL (1.69 mmol / L) but 130 mm Hg or diastolic blood pressure in sitting position> 85 mm Hg. 4) Altered basal glycemia (FPG> 100 mg / dL [5.5 mmol / L] and 18 years of age. d) It is very unlikely that the patient conceives. e) The patient understands the study procedures and agrees to participate in the study by giving written informed consent. f) The patient is able to read, understand and complete the study questionnaires.
Exclusion criteria
Exclusion criteria: a) The patient has a history or presence of a major psychiatric disorder. b) The patient has a diagnosis / episode / recurrence of stroke or recent neurological disorder. c) The patient has inadequately controlled hypertension. d) The patient has diabetes mellitus as defined in his medical history, or a fasting blood glucose> 126 mg / dL or random blood glucose> 200 mg / dL or uses antihyperglycemic drugs. e) The patient has any endocrinopathy, or the patient has an abnormal TSH level in the selection. f) The patient has a marked hypertriglyceridemia. g) The patient currently has a significant cardiovascular disease. h) The patient has an active liver disease or a history of chronic liver disease. i) The patient has a history of significant lung disease. j) The patient has a history or presence of a gastrointestinal disease. k) The patient has a history of significant kidney disease. l) The patient is HIV positive, as determined by his medical history. m) The patient has a history of neoplastic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Body weight: After evacuating the stomach, patients will only wear a gown, without shoes. There will be 3 measurements that should not differ by more than 0.20 kg, with a single electronic balance Tanita BWB-800-AS Waist circumference: Measured at the end of a minimum normal breath. The tape measure will be placed in a horizontal plane around the abdomen at the level of the iliac crest. 2 measurements will be recorded. Measure:Body weight. Waist circumference. Timepoints:Body weight: Weeks 2, 4, 8, 12, 16, 20, 24, 28,, 32, 36, 40, 44, 48, 52, 56.60, 64, 68, 72, 76, 80, 84, 88 , 92, 96, 100, 104, 108. Circumference of the waist: 0, 24, 50, 52, 76, | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Lipid profile: Triglycerides, HDL-C, subclasses LDL-C, non-HDL-C, LDL-C, total cholesterol. Insulin fasting. Insulin sensitivity. Fasting basal glucose (FPG). Adiponectin CRP Measure:Secondary effectiveness: Laboratory analysis Timepoints:Lipid profile: Triglycerides, HDL-C, subclasses LDL-C, non-HDL-C, LDL-C, total cholesterol. Insulin fasting. Fasting basal glucose (FPG): Weeks 0, 12, 36, 52, 64, 80, 96, 104. Adiponectin CRP: Weeks 0, 24, 52, 80 and 104 ; Outcome name:Peripheral blood samples for pharmacokinetic and pharmacogenomic analyzes Measure:Pharmacokinetic analysis. Pharmacogenomic analysis. Timepoints:Pharmacokinetic analyzes: Weeks 0, 4, 52, 80, 104 Pharmacogenomic analyzes: Weeks 0, ; Outcome name:Patient Health Survey (SF-36v2), Weight Impact on Quality of Life (IWQoL) and Health Status Assessment (EQ5D) Measure:Quality of life of the patient Timepoints:Weeks 0, 24, 52, 64, 80, 104 | — |
Countries
Hungary, Ireland, Italy, Sweden, United Kindgdom
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed